Process Manager (m/f/d) MSAT Upstream - 2 year contract

Kurz zusammengefasst

Rentschler Biopharma SE is a family‑owned contract development and manufacturing organization that supplies biopharmaceuticals for rare and serious diseases. With around 1,400 staff and sites in Germany and the United States, the company delivers full‑service bioprocess development and production for client projects, guided by a sustainability pledge and a collaborative "one team" culture. The Process Manager (m/f/d) will be responsible for the upstream portion of customers' active pharmaceutical ingredient (API) life cycles. Core duties include designing robust, scalable and cost‑effective upstream processes, scaling them up and transferring them across internal and external sites, and supporting qualification and validation at manufacturing scale. The role also defines control strategies, runs continued process verification, and owns the creation and review of process documentation, risk assessments and regulatory dossiers. Direct interaction with customers, cross‑functional teamwork, troubleshooting at scale, and participation in deviations, change management, audits and inspections are integral parts of the day‑to‑day work. Candidates must hold a university degree in biotechnology, pharmaceutical engineering, bioprocess engineering, chemical engineering or a comparable scientific field. They need several years of experience in upstream processing using scalable technologies for biopharmaceutical manufacturing, fluency in English, and proven expertise with commercial biotechnological processes. Experience in continued process verification, familiarity with statistical tools, and hands‑on involvement in process qualification/validation are also required. Strong communication, initiative, organizational skills and an entrepreneurial, analytical mindset are essential, while knowledge of downstream processing is considered a plus. The position offers meaningful work that directly supports patients with critical illnesses, a collegial atmosphere that values teamwork, and personal development through tailored training. Compensation includes an attractive salary, a 13th‑month payment, flexible working hours, remote‑work options, 30 vacation days, special leave, and a range of benefits such as health management, cafeteria meals, employee discounts, relocation support and free parking. What the role asks for: - University degree in biotechnology, pharmaceutical or chemical engineering - Multiple years of upstream processing experience in biopharma - Fluency in English - Experience with continued process verification (CPV) - Knowledge of statistical concepts and tools - Process qualification/validation (PPQ) experience - Strong communication and teamwork skills - Knowledge of downstream processing (nice‑to‑have)